The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Moss-miami Spinal System.
| Device ID | K974573 |
| 510k Number | K974573 |
| Device Name: | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cheryl K Hastings |
| Correspondent | Cheryl K Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-08 |
| Decision Date | 1998-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034033792 | K974573 | 000 |